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Health Care Vendor RelationsA new UCOP Presidential Policy

Lee Giddings, M.D.Chief Compliance Officer

UCSD Health Sciences

May 2008

Revised: 05/05/2008

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Vendor Relations – Outline

Introduction Background Key Elements Training Monitoring High Risk Areas

Key Elements:

I. Access

II. Gifts

III. Promotional Activity

IV. Preceptorships

V. Publicity of Support

VI. Anti-Kickback Law

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Vendor Relations – Introduction

“Policy on Health Care Vendor Relations” (PP031208) Approved: Officially signed by President Dynes – Mar. 12, 2008 Implementation: July 1, 2008 Endorsed by:

UC Academic Senate UC Chancellors UC Health Science Vice Chancellors

Work Group: Representation from all Health Science campuses Chaired by Rory Jaffe, M.D., Executive Director, Medical Services

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Vendor Relations – Introduction

Definition: Health Care Vendor. A company or its

representative or the agent of a company that either produces or markets drugs, devices, nutritional products, or other medical products or services.

Scope: All UCSD Health Science workforce members,

both on and off campus (unless specifically noted)

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Vendor Relations – Background

California Political Reform Act (CPRA) of 2001 Attempts to remove bias from product decisions Financial COI focus; does not eliminate all conflicts

Purpose of UCOP Policy To manage the perceived potential for industry unduly influencing health

care decisions Not a Conflict of Interest (COI) Policy

Supplements existing UC policies* Initiative Supported by:

AMC National Trends Evidence based literature (Brennan, JAMA 2006; 295 (4):429-433) Increased regulatory scrutiny

* Business & Finance Bulletin, G-39; COI Policy; Clinic Sample Policy, MCP 321.7; Regulations for Sales Representatives, MCP 550.1

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Vendor Relations – Key Elements

I. Vendor Access Vendors must register & wear ID badge (VendorClear);

(addresses patient confidentiality provisions) Vendors must have scheduled appointments Appointments in non-clinical areas only Can not access patient information without written consent

Anticipated FAQs Vendor may enter patient care areas if:

Pre-registered and requested by a UC representative Providing a specific health care support service Servicing equipment Or as a patient or member of the general public

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Vendor Relations – Key Elements

II. Vendor Gifts Prohibits gifts provided directly to individuals

Definition of Gift: Anything of value (including compensation) without providing a service of equivalent or greater value in exchange.

Examples of gifts: Free food, pens, notepads, supplies, books Free samples Free equipment Travel and lodging Paid attendance or registration fees for conferences

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Vendor Relations – Key Elements

II. Vendor Gifts - Anticipated FAQs:

The following are not considered a gift: Honoraria at Fair Market Value for legitimate service Food, travel, admission fee while providing a service Prizes or competitive awards Items provided at a discount or free as part of a University

contract or a research project Refreshments, non-cash nominal benefits and materials

provided by the organizers of a professional meeting and available to all attendees.

Example: CME Conference tote bags

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Vendor Relations – Key Elements

II. Vendor Gifts

Prohibits samples in all UCSDHS sites Prohibits samples for personal use

Alternatives: Vendor may donate “samples” for UC’s free clinics

Product must be on the UCSDMC formulary Product storage / distribution must adhere to regulatory

requirements

Vendor may donate “product” for evaluation or education purposes. The amount is restricted to the minimum necessary for the intended use. [Refer to MCP 405.1]

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Vendor Relations – Key ElementsII. Vendor Gifts

Alternatives: Patient Assistance Programs available through the UCSDMC

Pharmacy. Vendor may donate “funds” to support the mission of the University

(education, research, patient care)

Examples of Permitted Uses of Vendor Funds: -Educational meetings (non-CME)-Departmental Activities-Purchase of food-Purchase of travel-Fundraising activities-Grants *-Fellowships

Vendor can NOT:

-Select speakers

-Control content

-Select recipients

-Attend meetings

* Research grants from industry require 700-U form submission & IRB approval.

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Vendor Relations – Key Elements

II. Vendor Gifts

“Donations” must comply with standards and procedures of:

ACCME (or equivalent) http://www.accme.org/ UCSD Office of Continuing Medical Education (OCME)

(whether or not educational credit is offered) http://cme.ucsd.edu/ UCSD Office of Gift Administration (OGA) UCSD Office of Contracts & Grants Administration (OCGA) UCSD Conflict of Interest Office (COI) California Political Reform Act

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Vendor Relations – Key Elements

III. Vendor Promotional Material & Activity

Prohibits branded items with company logos in all UCSDHS sites

Prohibits meals, snacks, beverages directly provided by a vendor in all UCSDHS sites

Anticipated FAQs: Patient education materials which are branded and

needed for unique patient education purposes may be used at the discretion of individual providers, but should be free of all product promotion and bias.

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Vendor Relations – Key Elements

IV. Vendor Preceptorships

An educational program for vendor representative(s) Requires a written service agreement (Dean’s Office) &

oversight by UCSD OCME Requires compliance with HIPAA Privacy Rules & patient

consent in clinical areas Preceptorship must not provide a vendor with sales and

marketing opportunities

Anticipated FAQs: A vendor has the same access to official educational

offerings of the University as other members of the general public.

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Vendor Relations – Key Elements

V. Publicity of Industry Support California Public Records Act

Provides that information about industry support of the University is a public record

APM-025 Requires faculty to report annually time spent in outside

professional activity (OPA), which becomes a public record

VI. Anti-Kickback Law The Federal Anti-Kickback Statute prohibits the solicitation

or receipt of anything of value in return for patient referrals or to induce such referrals which could potentially be reimbursed by a government payer.

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Vendor Relations – Training

Vendors Registration process with Medical Center Purchasing

Department (VendorClear)

Workforce Members Train-the-trainer Faculty / Staff meetings Web postings Educational bulletins, memos, FAQs Learning management system (LMS) modules

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Vendor Relations – Monitoring Vendors

Enforce ID badge requirement Exclude from UCSDHS sites for repeated violations Send written report of violations / actions to company

Physicians Collaborate to build awareness / change culture Department Chair / physician leaders as champions & role models

Managers Discard branded items and literature Notify Pharmacy to retrieve samples for disposal Prohibit vendor provided food; notify Purchasing of violations

Committees Guidance and oversight by established UCSDHS Committees

Enforcement Corrective actions in accordance with UCSD & HR policies

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Vendor Relations – High Risk Areas

Activities to avoid… Sham honoraria or sham consulting agreements

Compensation should be an equivalent value for legitimate services

Luxurious off-site meetings & meals Entertainment unrelated to educational goals Free trips and tickets Speakers bureau & ghostwriting

Vendor control or influence of the content of a presentation is prohibited

Off-Label promotion (marketing)

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Vendor Relations – Safeguards

Managing HC Industry Vendor Relationships Disclose – financial relationships to Purchasing,

CME sponsor, audiences (learners) & patients Recuse – from product purchase decisions for 12

months Seek – advice from the UCSD Conflict of Interest

Office and your personal attorney Ask – assess your comfort level with potential

public exposure or scrutiny

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Questions?

Lee Giddings, M.D. Larry Friedman, M.D. Charles Daniels, Ph.D., R.Ph. Kathleen Naughton

UCOP policy site: “Policy on Health Care Vendor Relations” http://www.ucop.edu/ucophome/coordrev/policy/PP031208Policy.pdf Policy Issuance Letter – President Dynes (03/12/2008) http://www.ucop.edu/ucophome/coordrev/policy/PP031208.pdf